| K-number | K260976 |
| Device name | NeuroBlate System |
| Applicant | Monteris Medical |
| Product code | ONO |
| Device class | Class II |
| Decision date | Apr 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The NeuroBlate System is an MRI-guided laser surgical device for neurosurgery that ablates, necrotizes, or coagulates intracranial soft tissue including brain tumors, radiation necrosis, and epileptogenic foci using 1064 nm lasers. It provides MRI-based trajectory planning, real-time thermographic monitoring, and thermal therapy delivery under MRI visualization for adult and pediatric patients age 2 and older.
This submission adds Fast Scan capability to GE 1.5T MRI parameters with minor Instructions for Use updates. There are no physical changes, manufacturing changes, material changes, or technology changes to the NeuroBlate System itself; the technical modes of action and principles remain identical to the predicate device K240877.
The submission references ISO 13485 design controls, nonconforming product procedures, corrective action, and preventative action requirements. Human volunteer MRI scans were used to collect baseline tissue temperature data for validation of Fast Scan parameters.
The modified device presents no additional or different risks or technological characteristics compared to the predicate device. Fast Scan meets the same applicable requirements as previously described Siemens and GE 3.0T MRIs; observed data differences were determined to be not practically different and do not result in safety or performance differences. The fundamental functionality and technical characteristics are identical to the existing NeuroBlate System.
View the full FDA submission: accessdata.fda.gov